Ms. DeLauro
introduced the following bill; which was referred to the
Committee on Agriculture,
and in addition to the Committee on Energy
and Commerce, for a period to be subsequently determined by
the Speaker, in each case for consideration of such provisions as fall within
the jurisdiction of the committee concerned

A BILL

To amend the Federal Food, Drug, and Cosmetic Act and the
Federal Meat Inspection Act to require that food that contains product from a
cloned animal be labeled accordingly, and for other purposes.

1.

Short title

This Act may be cited as the
Cloned Food Labeling
Act.

2.

Amendments to the
Federal Food, Drug, and Cosmetic Act

(a)

In
general

Section 403 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at
the end the following:

(z)(1)

If it contains cloned
product unless it bears a label that provides notice in accordance with the
following:

(A)

A notice as follows: THIS
PRODUCT IS FROM A CLONED ANIMAL OR ITS PROGENY.

(B)

The notice required in clause (A) is
of the same size as would apply if the notice provided nutrition information
that is required in paragraph (q)(1).

(C)

The notice required under clause (A)
is clearly legible and conspicuous.

(2)

For purposes of this
paragraph:

(A)

The term cloned animal
means—

(i)

an animal produced as the result of
somatic cell nuclear transfer; and

(ii)

the progeny of such an
animal.

(B)

The term cloned product
means a product or byproduct derived from or containing any part of a cloned
animal.

(3)

This paragraph does not apply to food
that is a medical food as defined in section 5(b) of the Orphan Drug
Act.

(4)(A)

The Secretary, in
consultation with the Secretary of Agriculture, shall require that any person
that prepares, stores, handles, or distributes a cloned product for retail sale
maintain a verifiable recordkeeping audit trail that will permit the Secretary
to verify compliance with this paragraph and subsection (aa).

(B)

The Secretary, in consultation with
the Secretary of Agriculture, shall publish in the Federal Register the
procedures established by such Secretaries to verify compliance with the
recordkeeping audit trail system required under clause (A).

(C)

The Secretary, in consultation with
the Secretary of Agriculture, shall, on annual basis, submit to Congress a
report that describes the progress and activities of the recordkeeping audit
trail system and compliance verification procedures required under this
subparagraph.

(aa)

If it bears a
label indicating (within the meaning of subsection (z)) that it does not
contain cloned product, unless the label is in accordance with regulations
promulgated by the Secretary. With respect to such regulations:

(1)

The regulations
may not require such a label to include any statement indicating that the fact
that a food does not contain such product has no bearing on the safety of the
food for human consumption.

(2)

The regulations
may not prohibit such a label on the basis that, in the case of the type of
food involved, there is no version of the food in commercial distribution that
does contain such
product.

.

(b)

Civil
penalties

Section 303 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 333) is amended by adding at the end the following subsection:

(g)(1)

With respect to a
violation of section 301(a), 301(b), or 301(c) involving the misbranding of
food within the meaning of section 403(z) or 403(aa), any person engaging in
such a violation shall be liable to the United States for a civil penalty in an
amount not to exceed $100,000 for each such violation.

(2)

Paragraphs (3) through (5) of
subsection (f) apply with respect to a civil penalty under paragraph (1) of
this subsection to the same extent and in the same manner as such paragraphs
(3) through (5) apply with respect to a civil penalty under paragraph (1) or
(2) of subsection
(f).

Subject to section 403(z)(4), no
person shall be subject to the penalties of subsection (a)(1) or (h) for a
violation of section 301(a), 301(b), or 301(c) involving the misbranding of
food within the meaning of section 403(z) and 403(aa) if such person (referred
to in this paragraph as the recipient) establishes a guaranty or
undertaking signed by, and containing the name and address of, the person
residing in the United States from whom the recipient received in good faith
the food to the effect that (within the meaning of section 403(z)) the food
does not contain any cloned
product.

.

(2)

False
guaranty

Section 301(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(h)) is amended by inserting or 303(d)(2) after
303(c)(2).

(d)

Citizen
suits

Chapter III of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by
adding at the end the following section:

311.

Citizen suits
regarding misbranding of food with respect to product from cloned
animals

(a)

In
general

Except as provided in subsection (c), any person may on
his or her behalf commence a civil action in an appropriate district court of
the United States against—

(1)

a person who is
alleged to have engaged in a violation of section 301(a), 301(b), or 301(c)
involving the misbranding of food within the meaning of section 403(z) or
403(aa); or

(2)

the Secretary
where there is alleged a failure of the Secretary to perform any act or duty
under section 403(z) or 403(aa) that is not discretionary.

(b)

Relief

In
a civil action under subsection (a), the district court involved may, as the
case may be—

(1)

enforce the
compliance of a person with the applicable provisions referred to paragraph (1)
of such subsection; or

(2)

order the
Secretary to perform an act or duty referred to in paragraph (2) of such
subsection.

(c)

Limitations

(1)

Notice to
Secretary

A civil action may not be commenced under subsection
(a)(1) prior to 60 days after the plaintiff has provided to the Secretary
notice of the violation involved.

(2)

Relation to
actions of Secretary

A civil action may not be commenced under
subsection (a)(2) if the Secretary has commenced and is diligently prosecuting
a civil or criminal action in a district court of the United States to enforce
compliance with the applicable provisions referred to in subsection
(a)(1).

(d)

Right of
Secretary To intervene

In any civil action under subsection (a),
the Secretary, if not a party, may intervene as a matter of right.

(e)

Award of costs;
filing of bond

In a civil action under subsection (a), the
district court involved may award costs of litigation (including reasonable
attorney and expert witness fees) to any party whenever the court determines
such an award is appropriate. The court may, if a temporary restraining order
or preliminary injunction is sought, require the filing of a bond or equivalent
security in accordance with the Federal Rules of Civil Procedure.

(f)

Savings
provision

This section does not restrict any right that a person
(or class of persons) may have under any statute or common law to seek
enforcement of the provisions referred to subsection (a)(1), or to seek any
other relief (including relief against the
Secretary).

an animal produced
as the result of somatic cell nuclear transfer; and

(B)

the progeny of
such an animal.

(2)

Cloned
product

The term cloned product means a product or
byproduct derived from or containing any part of a cloned animal.

(3)

Cloned meat food
product

The term cloned meat food product means a
meat food product that contains a cloned product.

(b)

Labeling
requirement

(1)

Required
labeling to avoid misbranding

(A)

Involvement of
cloned meat food product

For purposes of sections 1(n) and 10, a
meat food product is misbranded if the meat food product—

(i)

is
a cloned meat food product; and

(ii)

does not bear a
label (or include labeling, in the case of a meat food product that is not
packaged in a container) that provides, in a clearly legible and conspicuous
manner, the notice described in subsection (c).

(B)

No involvement
of cloned meat food product

(i)

In
general

For purposes of sections 1(n) and 10, a meat food product
is misbranded if the meat food product bears a label indicating that the meat
food product is not a cloned meat food product, unless the label is in
accordance with regulations promulgated by the Secretary.

(ii)

Requirements

In
promulgating regulations referred to in clause (i), the Secretary may
not—

(I)

require a label to
include any statement indicating that the fact that a meat food product is not
a cloned meat food product has no bearing on the safety of the food for human
consumption; or

(II)

prohibit a label
on the basis that, in the case of the type of meat food product involved, there
is no version of the meat food product in commercial distribution that is not a
cloned meat food product.

(2)

Audit
verification system

(A)

In
general

The Secretary, in consultation with the Secretary of
Health and Human Services, shall require that any person that manufactures,
produces, distributes, stores, or handles a meat food product maintain a
verifiable recordkeeping audit trail that will permit the Secretary to verify
compliance with the labeling requirements described in paragraph (1).

(B)

Publication

The
Secretary, in consultation with the Secretary of Health and Human Services,
shall publish in the Federal Register the procedures established by the
Secretaries to verify compliance with the recordkeeping audit trail system
required under subparagraph (A).

(C)

Report

The
Secretary, in consultation with the Secretary of Health and Human Services,
shall, on an annual basis, submit to Congress a report that describes the
progress and activities of the recordkeeping audit trail system and compliance
verification procedures required under this paragraph.

(c)

Specifics of
label notice

(1)

Required
notice

The notice referred to in subsection (b)(1)(A)(ii) is the
following: THIS PRODUCT IS FROM A CLONED ANIMAL OR ITS
PROGENY.

(2)

Size

The
notice required in paragraph (1) shall be of the same size as if the notice
provided nutrition information that is required under section 403(q)(1) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(q)(1)).

(d)

Guaranty

(1)

In
general

Subject to subsection (b)(2) and paragraph (2), a person
engaged in the business of manufacturing or processing meat food products, or
selling or serving meat food products at retail or through a food service
establishment (referred to in this subsection as the recipient)
shall not be considered to have violated this section with respect to the
labeling of a meat food product if the recipient establishes a guaranty or
undertaking signed by, and containing the name and address of, the person
residing in the United States from whom the recipient received in good faith
the meat food product or the animal from which the meat food product was
derived, or received in good faith food intended to be fed to the animal, to
the effect that the meat food product, or the animal, or the meat food product,
respectively, does not contain a cloned product or was not produced with a
cloned product.

(2)

Audit
verification system

In the case of recipients who establish
guaranties or undertakings in accordance with paragraph (1), the Secretary may
exempt the recipients from the requirement under subsection (b)(2) regarding
maintaining a verifiable recordkeeping audit trail.

(3)

False
guaranty

It is a violation of this Act for a person to give a
guaranty or undertaking in accordance with paragraph (1) that the person knows
or has reason to know is false.

(e)

Civil
penalties

(1)

In
general

The Secretary may assess a civil penalty against a person
that violates subsection (b) or (c) in an amount not to exceed $100,000 for
each violation.

(2)

Notice and
opportunity for hearing

(A)

In
general

A civil penalty under paragraph (1) shall be assessed by
the Secretary by an order made on the record after opportunity for a hearing
provided in accordance with this paragraph and section 554 of title 5, United
States Code.

(B)

Written
notice

Before issuing an order under subparagraph (A), the
Secretary shall—

(i)

give written
notice to the person to be assessed a civil penalty under the order of the
proposal of the Secretary to issue the order; and

(ii)

provide the
person an opportunity for a hearing on the order.

(C)

Authorizations

In
the course of any investigation, the Secretary may issue subpoenas requiring
the attendance and testimony of witnesses and the production of evidence that
relates to the matter under investigation.

(3)

Considerations
regarding amount of penalty

In determining the amount of a civil
penalty under paragraph (1), the Secretary shall consider—

(A)

the nature,
circumstances, extent, and gravity of the 1 or more violations; and

(B)

with respect to
the violator—

(i)

ability to
pay;

(ii)

effect on ability
to continue to do business;

(iii)

any history of
prior violations;

(iv)

the degree of
culpability; and

(v)

such other matters
as justice may require.

(4)

Certain
authorities

(A)

In
general

The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty under paragraph (1).

(B)

Deduction from
sums owed

The amount of a civil penalty under this subsection,
when finally determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person charged.

(5)

Judicial
review

(A)

In
general

Any person who requested, in accordance with paragraph
(2), a hearing respecting the assessment of a civil penalty under paragraph (1)
and who is aggrieved by an order assessing a civil penalty may file a petition
for judicial review of the order with—

(i)

the United States
Court of Appeals for the District of Columbia Circuit; or

(ii)

any other circuit
in which the person resides or transacts business.

(B)

Filing
deadline

A petition described in subparagraph (A) may only be
filed within the 60-day period beginning on the date the order making the
assessment was issued.

(6)

Failure to
pay

(A)

In
general

The Attorney General shall recover the amount assessed
under a civil penalty (plus interest at prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (5)(B) or the date of
the final judgment, as appropriate) in an action brought in any appropriate
district court of the United States if a person fails to pay the
assessment—

(i)

after the order
making the assessment becomes final, if the person does not file a petition for
judicial review of the order in accordance with paragraph (5)(A); or

(ii)

after a court in
an action brought under paragraph (5) has entered a final judgment in favor of
the Secretary;

(B)

Exemptions from
review

In an action described in subparagraph (A), the validity,
amount, and appropriateness of the civil penalty shall not be subject to
review.

(f)

Citizen
suits

(1)

In
general

Except as provided in paragraph (3), any person may on
his or her behalf commence a civil action in an appropriate district court of
the United States against—

(A)

a person who is
alleged to have engaged in a violation of subsection (b) or (c); or

(B)

the Secretary in a
case in which there is alleged a failure of the Secretary to perform any act or
duty under subsection (b) or (c) that is not discretionary.

(2)

Relief

In
a civil action under paragraph (1), the district court involved may, as
appropriate—

(A)

enforce the
compliance of a person with the applicable provisions referred to paragraph
(1)(A); or

(B)

order the
Secretary to perform an act or duty referred to in paragraph (1)(B).

(3)

Limitations

(A)

Notice to
Secretary

A civil action may not be commenced under paragraph
(1)(A) prior to 60 days after the date on which the plaintiff provided to the
Secretary notice of the violation involved.

(B)

Relation to
actions of Secretary

A civil action may not be commenced under
paragraph (1)(B) if the Secretary has commenced and is diligently prosecuting a
civil or criminal action in a district court of the United States to enforce
compliance with the applicable provisions referred to in paragraph
(1)(A).

(4)

Right of
Secretary to intervene

In any civil action under paragraph (1),
the Secretary, if not a party, may intervene as a matter of right.

(5)

Award of costs;
filing of bond

(A)

Award of
costs

In a civil action under paragraph (1), the district court
involved may award costs of litigation (including reasonable attorney and
expert witness fees) to any party in any case in which the court determines
such an award is appropriate.

(B)

Filing of
bond

The court may, if a temporary restraining order or
preliminary injunction is sought, require the filing of a bond or equivalent
security in accordance with the Federal Rules of Civil Procedure.

(6)

Savings
provision

This subsection does not restrict any right that a
person (or class of persons) may have under any statute or common law—

(A)

to seek
enforcement of the provisions referred to in paragraph (1)(A); or